Kornimate/medical-research-clean huggingface dataset:
comparative efficacy of 4 oral analgesics

Conditions: Pain

Summary: the purpose of this study is to perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ed.

to perform a randomized, double blind 4-arm clinical trial of the comparative efficacy of 4 oral analgesics in the initial management of acute musculoskeletal extremity pain presenting to the ed. the 4 groups are as follows: 1. oxycodone/acetaminophen (5/325) 2. hydrocodone/acetaminophen (5/325) 3. codeine/acetaminophen (30/300) 4. ibuprofen/acetaminophen (400/1000)

Eligibility criteria:
inclusion criteria: * complaint of acute pain of \< 7 days duration * location of pain in one or more extremities defined as distal to and including the shoulder joint in the upper extremities and distal to and including the hip joint in the lower extremities; * radiologic evaluation is planned exclusion criteria: * inability to confirm reliable means of phone followup. * past use of methadone * chronic condition requiring frequent pain management such as sickle cell disease, fibromyalgia, or any neuropathy * history of an adverse reaction to any of the study medications * opioids taken in the past 24 hours * ibuprofen or acetaminophen taken in past 8 hours * pregnancy by either urine or serum hcg testing * breastfeeding per patient report * history of peptic ulcer disease * report of any prior use of recreational narcotics * medical condition that might affect metabolism of opioid analgesics, acetaminophen, or ibuprofen such as hepatitis, renal insufficiency, hypo- or hyperthyroidism, addison's or cushing's disease * taking any medicine that might interact with one of the study medications, such as antidepressant ssri's or tricyclics, antipsychotics, anti-malaria medications quinidine or halofantrine, amiodarone or dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritanovir, terbinafine, or st john's wort.

Keywords: pain
a clinical study of shp674 (pegaspargase) in participants with newly diagnosed, untreated acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia

Summary: the objectives of the study are to assess the safety and tolerability of a single dose of shp674 in japanese participants (dose confirmation) in the tolerability assessment period of part 1 and to assess the safety, pharmacokinetics and efficacy of shp674 dose in part 2 (found to be tolerated in part 1) in the treatment of newly diagnosed untreated acute lymphoblastic leukemia (all) in japanese participants.


Eligibility criteria:
inclusion criteria: * age 1 to ≤21 years at the time of informed consent; * eastern cooperative oncology group performance status (ecog ps) 0 to 2; * newly diagnosed, untreated precursor b-cell all * no prior therapy for malignant tumor such as chemotherapy and radiation therapy before signing the informed consent; * life expectancy of at least 6 months from the date of enrollment; exclusion criteria: * mature b-cell all ; philadelphia chromosome-positive (ph+) or bcr-abl1-positive all * preexisting known coagulopathy ; * history of pancreatitis; * continuous use of corticosteroids; * prior treatment or possible prior treatment with an l-asparaginase preparation; * history of sensitivity to polyethylene glycol (peg) or peg-based drugs; * pregnant

Keywords: acute lymphoblastic leukemia
auricular vns following subarachnoid hemorrhage

Conditions: Subarachnoid Hemorrhage

Summary: this study will evaluate whether non-invasive auricular vagal nerve stimulation lowers inflammatory markers, and improves outcomes following spontaneous subarachnoid hemorrhage.

vagal nerve stimulation (vns) has been studied in several inflammatory conditions, and has been implemented in animal models of subarachnoid hemorrhage (sah) with promising results. the purpose of the proposed study is to determine how applying auricular vns in patients presenting with spontaneous sah impacts their expression of inflammatory markers in their blood and cerebrospinal fluid (csf), and how it impacts their clinical course and outcomes. this study will involve randomizing patients to stimulation with vns, or sham stimulation. blood and csf will be collected on admission, and serially throughout the patient's admission. clinical events tracked during the hospital stay include development of cerebral vasospasm, need for csf diversion via a shunt, stress-induced cardiomyopathy, and development of stroke or global cerebral ischemia. outcomes following admission will include functional scores at discharge, and at follow-up visits for up to 2 years after discharge.

Eligibility criteria:
inclusion criteria: * spontaneous subarachnoid hemorrhage exclusion criteria: * trauma-induced subarachnoid hemorrhage * ongoing chemotherapy * taking immunosuppressive medications for other medical illnesses * presence of a pacemaker * prolonged bradycardia at time of admission

Keywords: vagal nerve stimulation
a study to evaluate the safety and tolerability of long-term administration of gantenerumab in participants with alzheimer's disease (ad)

Conditions: Alzheimer Disease

Summary: the main purpose of the study was to evaluate the safety and tolerability of long-term administration of gantenerumab in participants with ad. all participants who have completed the open-label extensions (oles) of studies wn25203 or wn28745 were enrolled in part 1 of this study. of these, participants who completed week 104 visit in part 1. participants received open-label gantenerumab by subcutaneous (sc) injection every four weeks (q4w) at the same dose as administered in the parent studies (part 1)/ week 104 visit.


Eligibility criteria:
inclusion criteria: * part 1: participants who completed the open-label extensions (oles) of studies wn25203 or wn28745 will be eligible to participate in part 1 of the study * part 2: all participants who have completed week 104 visit in part 1 will be eligible for part 2 of the study * for part 1 and part 2: * for women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 16 weeks after the last dose of study drug * agreement to not donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug * availability of a person ('caregiver') who in the investigator's judgement, has frequent and sufficient contact with the participant exclusion criteria: * prematurely discontinued from the oles of studies wn25203 or wn28745 or from study drug for any reason * any medical condition that may jeopardize the participant's safety if he or she continues to receive study treatment * if the participant is unlikely to benefit from gantenerumab therapy, based on disease progression or other factors, or if study participation is otherwise not in the participant's best interest * any investigational treatment other than gantenerumab during or since completion of the oles of studies wn25203 or wn28745 * pregnancy * evidence of disseminated leptomeningeal hemosiderosis (i.e., more than three focal leptomeningeal hemosiderosis) * evidence of intracerebral macrohemorrhage * part 2: participants who have been discontinued from part 1 of the study
simvastatin as a treatment for pulmonary hypertension

Conditions: Pulmonary Hypertension

Summary: the purpose of the study is to investigate the safety and efficacy of adding simvastatin to the current conventional treatment regimen for the management of pulmonary hypertension.

pulmonary arterial hypertension (pah) is a disease that is characterised by progressive narrowing of the blood vessels of the lungs. this results in a pressure load on the heart and heart failure. the narrowing is in part due to constriction but mostly due to structural changes in affected vessels. the structural changes affect all cell components of the vessel wall (the endothelial lining, the muscle layer and fibrous tissue) and can lead to local clot formation. in addition there is evidence of inflammation of the vessels and what is known as oxidative stress. the disease may occur with no obvious cause, when it is known as idiopathic, but it can also be associated with a variety of other diseases, including congenital heart disease, collagen vascular disease and hiv infection. current approaches to the treatment of pulmonary hypertension are unsatisfactory as they do not prevent disease progression and do not directly or adequately address many of the processes detailed above. alternative or additional treatments are therefore required and an attrative approach is to use a statin (a 3-hydroxy-3-methylglutaryl-coenzymea, or hmg-coa, reductase inhibitor). statins are widely used for their ability to lower blood cholesterol but increasing evidence indicates that these drugs also have direct effects on cell components of the vessel wall - including inhibiting inflammation, clot formation and oxidative stress - that might be beneficial in pulmonary hypertension.

Eligibility criteria:
inclusion criteria: * patients with idiopathic pah or pah related to collagen vascular disease * age 18 years or over * receiving conventional therapy with diuretics, digoxin, warfarin, sildenafil and bosentan. stable for 1 month * 6 minute walk distance between 150m and 450m * modified nyha functional class ii or iii exclusion criteria: * pah from a cause other than permitted by entry criteria * change in pah treatment in past 4 weeks * patients requiring prostanoid therapy * patients already taking a statin * clinically significant disturbance of liver function - ast or alt \>3xulm; bilirubin \>1.5xulm * contraindication for a magnetic resonance scan

Keywords: pulmonary hypertension simvastatin statins
impact of hpv vaccination to catch up in the emergence of lesions of the cervix

Conditions: HPV Vaccination; Pap Smear; Cervical Cancer; Catch-up Vaccination

Summary: in france, the vaccination coverage observed for hpv vaccination is low for a full-scale regimen, and has been falling since 2010. a high rate of hpv vaccination coverage has a significant epidemiological impact with a reduction in cervical cancer mortality. there is less data on vaccinated catch-up patients. in 2017, these patients are 25 years of age or older and carry out screening smears. the aim of this study is to demonstrate whether hpv catch-up vaccination results in a decrease in the abnormal smear rate compared to the rate in unvaccinated patients. if so, these data will help mobilize doctors to vaccinate patients against hpv, even in catching-up.

in france, the observed vaccination coverage is very low for a complete regimen and has been declining since 2010. this low coverage makes it impossible to benefit from the efficiency observed in the other countries. indeed, a high hpv vaccination coverage rate would allow an epidemiologically significant impact with a reduction in cervical cancer mortality. in france, it is estimated that the vaccination of 80% of girls between the ages of 11 and 14 would reduce the incidence of 72% of cin2 and 54% of cin3. nevertheless, there is less data on patients who have been vaccinated in catch-up. these patients are 25 years of age or older in 2017, and make smears. the aim of this study is to demonstrate whether hpv catch-up vaccination results in a decrease in the abnormal smear rate compared to the rate in unvaccinated patients. if our study shows the benefits of catch-up vaccination, these data will help to mobilize doctors to vaccinate girls 15-19 years of age against hpv if they have not been able to benefit between 11 and 14 years as recommended.

Eligibility criteria:
inclusion criteria: * women * aged 25 to 33 in 2017 * with a smear analyzed at the brest university hospital exclusion criteria: * men * age over 33 years or less than 25 years * patient refusing to participate
evaluation effects of treatment with il-6r inhibitor on clinical response and biomarkers in patients with rheumatoid arthritis (ra) not responding to dmards and/or a first biological agent.

Conditions: Rheumatoid Arthritis (RA)

Summary: the purpose of this study is to assess the clinical response to il-6 inhibition defined as low disease activity (das44) \<2.4) at the follow-up visit at 12 months and the correlation between the biomarkers and treatment response.


Eligibility criteria:
inclusion criteria: * signed informed consent form; * patients aged 18 - 75 years; * ra classified in compliance with the 2010 acr/eular criteria; * patients that have to suspend a previous treatment with dmards for total ineffectiveness or intolerance to drugs and/or patients that have not responded adequately to first-line combination dmards / biological treatment; * patients for which is indicated to start a treatment with an inhibitor of il-6r for high values indicative of systemic inflammation (esr\>=28 mm/hour, pcr\>5 mg/l , fibrinogen \>400 mg/dl and or albumin \ 2.4), or contraindications to dmards use which make it necessary to take biological drug in monotherapy. * corticosteroids therapy stable (\< = 7.5 mg)for at least four weeks; * joint symptoms for at least three but no more than 24 months from the screening visit; * das44 \>2.4 and/or sdai \>11 * willing and able to comply with study procedures and timing. exclusion criteria: * on going pregnancy or lactation; * severe active infections; * patients with other clinically significant concomitant diseases whose treatment or outcome could interfere with the expected evaluations of the study protocol. * blood ast or alt levels \>5 times the upper normal limit; * anc count \<0.5 x 109/l * platelet count \<50 x103 /μl * patients with other autoimmune rheumatic diseases, in addition to ar (for example systemic lupus erythematosus \[sle\], scleroderma, polymyositis, ecc...) * medical history or concomitant joint diseases in additions to ar (for example tophaceous gout, reactive arthritis, psoriatic arthritis).

Keywords: rheumatoid arthritis early ra ra il-6 il-6r inhibitor inhibition tocilizumab biomarkers dmards biological das sdai ar/biom oeg
afr10 - combination therapy of imatinib mesylate (im) + alpha-2a interferon for chronic phase cml patients resistant or refractory to im used as single therapy for at least one year

Conditions: Chronic Myeloid Leukemia

Summary: sixty % of cml patients treated by imatinib mesylate achieved a major cytogenetic responses (ccr) at 18 months. so, 40% of the patients must receive additional treatment. in vitro, it has been shown that im and interféron-alpha have synergic anti-proliferative effect on chromosome ph+ cell lines. by using peg-interféron and im combination, we hope to increase the cytogenetic response of patients.


Eligibility criteria:
inclusion criteria: * chronic phase philadelphia positive cml, confirmed by karyotyping (or fish) analysis, in complete hematologic response with im. * lack of major cytogenetic response after at least one year of sti 571 as single therapy. * male and female \* 18 years old. * informed consent signed up. * performance status grade 0 - 2 (ecog). * sgot and sgpt \<3n * serum bilirubin \< 1.5 n * serum creatinine \< 1.5 n * no hsc graft planned * b-hcg negative for female with potential childbearing exclusion criteria: * absence of complete hematologic response * extramedullar involvement * previous extra-hematologic intolerance of interféron at a dose superior or equal to 25 mui/week * depressive syndrome not controlled * not controlled dysthyroidy * auto-immune pathology not controlled * women with childbearing potential who are unwilling or unable to use an adequate method to avoid pregnancy for the entire period of the study * significant cardiac disease (grade 3 or more) * known seropositivity for hiv * active viral hepatitis * other malignant disease * other experimental medication

Keywords: chronic myeloid leukaemia resistant refractory imatinib mesylate
early multimodal neuromonitoring for spontaneous intracerebral hemorrhage (ich)

Conditions: Intracerebral Hemorrhage; Critically Ill; Intracranial Pressure; Cerebral Perfusion Pressure; Prognostic

Summary: the investigators intend to assess the predictive value of early (first 48 hours) multimodal neuromonitoring parameters concerning late survival in critically ill intracerebral hemorrhage (ich) patients.

retrospective observational study based on analyzing the first 48 hours of the multimodal neuromonitoring signal, from spontaneous ich patients, whose treatment includes invasive intraparenchymal neuromonitoring, treated from january 2015 to september 2021 in a tertiary hospital.

Eligibility criteria:
inclusion criteria: * spontaneous intracerebral hemorrhage * icu admission * need of sedation and ventilatory support * need of intracerebral neuromonitoring exclusion criteria: * etiology for intracerebral hemorrhage such as tumor, vascular malformation, ischemic transformation.
wrist cooling for hot flashes clinical trial

Conditions: Hot Flashes

Summary: this pilot randomized double blind controlled crossover study aims to determine the impact of two wrist cooling devices on symptom control of hot flashes in adult men and adult women experiencing hot flashes. the participants will record during the first two weeks of the study all of their hot flashes and severity of their hot flashes in a diary. the participants will be randomly assigned to wear one of the two wrist cooling devices that have an identical appearance at different times in the study. they will wear the first assigned device for weeks 3 and 4. they will record in their diary the severity of their hot flashes while using the device. for weeks 5 and 6 they will be ask to use a second device and record in their diary the severity of their hot flashes with the use of the device. the devices will be attached to the wrist like a watch. when activated, one device will turn on a cooling fan with the cooling plate being active for up to 5 minutes, and the other device will turn on a cooling fan only for up to 5 minutes without the cooling plate being active.

the randomized group will determine the order that a participant uses each device. group 1 participants will use the wrist cooling device first for two weeks and then the fan activating device for two weeks. group 2 participants will use the fan activating device first for two weeks followed by the wrist cooling device for two weeks. this will be a 6 week study requiring the participants to see a study team member at the beginning of the study. the participants will receive three phone calls during the study to remind them of when to use each device. they will be instructed after the 6 weeks for them to have an in person return visit and give the diaries and the devices to the study personnel. the investigators will recruit participants and conduct the study at the boston university school of medicine (busm), locally, and virtually.

Eligibility criteria:
inclusion criteria: 1. experiencing at least 2 hot flashes per day that are either moderate and/or severe in severity. 1. moderate: sensation of heat with sweating/dampness but able to continue activity with only brief fanning needed 2. severe: sensation of intense heat with sweating and causing disruption of current activity 2. english speaking exclusion criteria: 1. temperature sensitivity due to cooling associated with an autoimmune or vascular disorder, such as raynaud's phenomena, peripheral arterial disease or any other reasons. 2. any wrist skin sensitivity that is known to cause discomfort when any type of device such as a wristwatch is placed on the wrist. 3. any lack of sensitivity to coolness on the wrists or hands 4. any use of pharmaceuticals or devices to treat hot flashes. 5. unable to understand and speak english

Keywords: breast cancer prostate cancer hormone deprivation therapy wrist cooling device
comparison of transthoracic electrical bioimpedance and pulse contour analysis in renal transplantation patients

Conditions: Hemodynamic Monitoring

Summary: hemodynamics monitoring using non-invasive transthoracic electrical bioimpedance icon are compatible with standard invasive monitoring using pulse contour analysis ev1000


Eligibility criteria:
inclusion criteria: * bmi 18.5 - 35 kg/m\^2 exclusion criteria: * heart function abnormalities (arrhythmia, av block, using pacemaker, severe aorta stenosis) * morbid obesity * bradycardia (\< 50 bpm) * tachycardia (\> 110 bpm) * refuse to participate

Keywords: bio-impedance haemodynamic monitoring pulse contour analysis kidney transplantation
the effect of crossfit kids on social skills in children with autism spectrum disorder (crossfit kamp)

Conditions: Autism Spectrum Disorder

Summary: the centers for disease control and prevention estimates that 1 in 59 u.s. children have been diagnosed with an autism spectrum disorder (asd). peer relationships, social skills, and repetitive behaviors are a challenge for those with asd. exercise in the asd population has been examined as a means to improve some of these challenges for children with asd. this research study will try to see if a structured exercise program called crossfit kids can help with these challenges. this study is potentially beneficial in developing an exercise program for children with asd that can help promote social skill development, reduce stereotypical behaviors, and provide overall health benefits.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of autism spectrum disorder * full scale iq \>80 on standardized testing * english speaking * parents must be able to bring children to class twice a week for 14 weeks. exclusion criteria: * non-english speaking * medical condition or physical impairment precluding them from safely participating in classes (eg. spastic quadriplegic cerebral palsy, critical congenital heart disease, uncontrolled asthma, uncontrolled seizure disorder, etc.)

Keywords: asd, autism spectrum disorder
comparison of two oral appliances in the treatment of sleep apnea syndrome

Conditions: Obstructive Sleep Apnea

Summary: monocentric comparative group study comparing the efficacy and short-term tolerance of a propulsion type oral appliance (herbst) with a retention type device (orm) used in the treatment of sleep apnea syndrome. the investigators hypothesized both appliances would be equally effective and tolerated.


Eligibility criteria:
inclusion criteria: * sufficient teeth to allow wearing of the device * mild to severe osas * ability to answer the questionnaires * no concomitant cpap treatment * bmi inferior to 32 kg/m2 exclusion criteria: * important dental or parodontal disease * central sleep apnea * jaw opening limitations * temporo-mandibular joint dysfunction * major gag reflex precluding the long-term use of the device * major or unstable cardiovascular or pulmonary disease
vulnerability and therapeutic changes in older patients with multiple myeloma.

Conditions: Multiple Myeloma in Older Patients

Summary: the aim of this study is to determine whether the presence of vulnerability detected by geriatricians is associated with treatment discontinuation in older patient. during the comprehensive geriatric assessment realized before the decision-treatment, the following data are recorded and their impact in the therapeutic changes will also be analysed: comorbidity, age, depression, functional status, the cognitive impairment and malnutrition.


Eligibility criteria:
inclusion criteria: * patients aged 70 years and older * patients referred for a assessment of a newly diagnosed multiple myeloma * patients for who the initial therapy proposed is either melphalan-prednisone-thalidomide or melphalan-prednisone-bortezomib or included in a phase 3 trial. * patients who provide informed written consent exclusion criteria: * patients who refuse the study * patients who won't have therapy * patients can't respond to geriatric assessment because of severe cognitive disorder * patients with a legal guardian

Keywords: multiple myeloma, older patient, treatment, geriatric assessment